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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AV-TEMECULA-CT NC TREK CORONARY DILATATION CATHETER

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AV-TEMECULA-CT NC TREK CORONARY DILATATION CATHETER Back to Search Results
Catalog Number 1012451-15
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Intimal Dissection (1333)
Event Date 11/10/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. There was no reported device malfunction and the product was not returned. The reported patient effect of intimal dissection is listed in the coronary dilatation catheters (cdc), nc trek rx, global , instructions for use as a known patient effect. Based on the case information and related record review, a conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined; however, the treatment appears to be related to the operational context of the procedure. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event. The absorb gt1 referenced is being filed under a separate medwatch report number.
 
Event Description
It was reported that the procedure was to treat an occluded left anterior descending artery. The patient presented with an st elevated myocardial infarction (stemi). Pre-dilatation was performed with a 2. 5 nc trek balloon catheter and then a 3. 5 x 15 mm nc trek balloon catheter. After the second pre-dilatation of the 3. 5 x 15 mm nc trek, a dissection occurred. A 3. 5 x 28 mm absorb gt1 scaffold was deployed at 16 atmospheres which covered the dissection and post-dilatation was performed with a 3. 75 x 15 mm nc trek balloon catheter. Optical coherence tomography (oct) was performed which showed a dissection proximal to the scaffold. There was no malapposition of the scaffold. There was also thrombus observed in a distal side branch. It is unknown if the thrombus occurred before the procedure as the patient presented with an mi or if it occurred due to the dissection. A xience stent was implanted to cover the dissection overlapping the scaffold 1 mm. Oct was again performed and the scaffold was still apposed to the vessel wall. The results were good and the patient is doing fine. There was no clinically significant delay in the procedure. No additional information was provided.
 
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Brand NameNC TREK CORONARY DILATATION CATHETER
Type of DeviceCORONARY DILATATION CATHETER
Manufacturer (Section D)
AV-TEMECULA-CT
abbott vascular
26531 ynez road
temecula CA 92591 4628
Manufacturer (Section G)
EL COYOL, COSTA RICA REG# 3009031392
abbott vascular
26531 ynez road
temecula CA 92591 4628
Manufacturer Contact
connie speck
abbott vascular
26531 ynez road
temecula, CA 92591-4628
9519143996
MDR Report Key6117588
MDR Text Key60546883
Report Number2024168-2016-08182
Device Sequence Number1
Product Code LOX
UDI-Device Identifier08717648151989
UDI-Public(01)08717648151989(17)190831(10)60906G1
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K110134
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 11/21/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/21/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/31/2019
Device Catalogue Number1012451-15
Device Lot Number60909G1
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/10/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/01/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/21/2016 Patient Sequence Number: 1
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